Jul 9 2010
PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a grant from the National Institute of Health (NIH) to support the development of defensin-mimetic antimicrobial compounds for the treatment of malaria.
Malaria is a devastating global disease with up to 3 billion people exposed, and causes more than one million deaths each year as resistance to current therapies increases. PolyMedix’s defensin-mimetic antimicrobial compounds offer a potentially new approach for treating malaria, with a mechanism of action to which resistance is unlikely to develop.
The initial phase of this grant provides PolyMedix with $0.5 million over the first year, with the opportunity for an additional $0.5 million in the second year, to validate and pursue defensin-mimetic antimicrobial compounds for therapeutic development. The goal of the first phase of research is to generate proof-of-concept through in vitro and in vivo efficacy testing. Subject to satisfactory performance of the initial phase and availability of funds, the grant provides for funding of up to $1 million per year for each of an additional three years, which brings the potential value of the grant up to an aggregate of $4 million over the five year period. This award represents the 13th grant or research contract received to date by PolyMedix.
Malaria is a life-threatening disease caused by a parasite called Plasmodium, which is transmitted to people by infected mosquitoes. As much as half of the world’s population, up to 3 billion people may be exposed to malaria. In the human body, the parasites multiply in the liver, and then infect red blood cells. According to the World Health Organization, the inappropriate use of antimalarial drugs during the past century, including poor management of use, deployment of drugs on a large scale and use as monotherapies, has contributed to the current situation of unacceptably high levels of resistance. This growing resistance to antimalarial medicines has spread very rapidly, undermining malaria control efforts.
“Current therapies for malaria are plagued by increasingly rapid drug resistance, which has become endemic in certain regions of the world,” commented Richard Scott, Vice President of Research at PolyMedix. “Our defensin-mimetic antimicrobial compounds mimic human host-defense proteins and have a mechanism of action distinct from those of current anti-malarial drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. In preclinical studies, two of our compounds, PMX-70008 and PMX-30024, have demonstrated encouraging in vitro specificity for Plasmodium, the most deadly malaria parasite. With this funding from the NIH we are able to continue our research in developing a compound to potentially address this major unmet medical need.”
As presented at the American Society of Microbiology ICAAC conference in 2008 by Dr. Doron Greenbaum of the University of Pennsylvania, pre-clinical studies with PolyMedix’s defensin mimetic antibiotics showed encouraging activity for the potential treatment of the malaria parasite, Plasmodium falciparum, the infectious agent for the most prevalent and deadly forms of malaria. P. falciparum accounts for 80% of all human malarial infections and 90% of deaths from such infections. More than 120 million new clinical cases of malaria and between 1 to 1.5 million deaths occur worldwide every year.
PolyMedix’s small molecule defensin-mimetic antimicrobial compounds are designed to mimic human host defense proteins, one of the oldest and most effective antimicrobial defense systems found in virtually all living creatures. Host defense proteins use a simple, but effective method for killing bacteria by targeting bacterial membranes and disrupting them. This mechanism of action makes it difficult for bacteria to develop resistance.
PolyMedix’s lead small molecule defensin mimetic antibiotic compound, PMX-30063, has completed two Phase 1 clinical trials. Results from the studies demonstrated that PMX-30063 could be safely administered in single or divided doses, at levels that exceeded theoretical efficacious levels predicted by animal models. In addition, PMX-30063 killed Staph bacteria, including MRSA, in human serum in blood samples drawn from subjects in the study. PolyMedix is working towards starting a Phase 2 efficacy study in patients with Staph infections with PMX-30063.